Retraining Attention to Treat Alcohol Dependence and Social Anxiety (AMP)
Primary Purpose
Alcohol Drinking, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Attention Training
Alcohol Attention Training
Control Training
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol Abuse, Alcohol Dependence, Alcohol Drinking, Social Anxiety, Social Phobia, Anxiety Disorders
Eligibility Criteria
Inclusion Criteria:
- Current alcohol dependence
- Elevated social anxiety symptoms
- Willingness to consider cutting down on drinking
Exclusion Criteria:
- Current psychosis
- Unmanaged manic symptoms
- Significant cognitive impairment
- Other drug use in past month
- Receiving cognitive behavioral therapy for alcohol use disorder or social anxiety
- Unable to read
Sites / Locations
- University of Cincinnati Department of Family and Community Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Anxiety Attention Training only
Alcohol Attention Training only
Anxiety + Alcohol Attention Training
Control Training
Arm Description
Participants will receive Anxiety Attention Training and placebo Alcohol training.
Participants will receive Alcohol Attention Training and placebo Anxiety training.
Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Participants will receive placebo Anxiety Training and placebo Alcohol training.
Outcomes
Primary Outcome Measures
Liebowitz Social Anxiety Scale
The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).
The Daily Drinking Questionnaire
The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.
Secondary Outcome Measures
Full Information
NCT ID
NCT01886716
First Posted
June 17, 2013
Last Updated
December 15, 2016
Sponsor
University of Cincinnati
Collaborators
Miami University, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT01886716
Brief Title
Retraining Attention to Treat Alcohol Dependence and Social Anxiety
Acronym
AMP
Official Title
Cognitive Bias Modification: A Novel Intervention for Alcohol Dependence and Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Miami University, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
Detailed Description
Alcohol Use Disorders (AUDs) and Social Anxiety Disorder are disabling and chronic conditions. In spite of these common and significantly overlapping problems, insight into the mechanisms linking alcohol dependence and social anxiety symptoms is minimal, and there are not well established treatment guidelines for this population. In this study, the investigators seek to develop a computerized intervention for individuals with symptoms of social anxiety and alcohol dependence. The intervention attempts to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Anxiety Disorders
Keywords
Alcohol Abuse, Alcohol Dependence, Alcohol Drinking, Social Anxiety, Social Phobia, Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anxiety Attention Training only
Arm Type
Experimental
Arm Description
Participants will receive Anxiety Attention Training and placebo Alcohol training.
Arm Title
Alcohol Attention Training only
Arm Type
Experimental
Arm Description
Participants will receive Alcohol Attention Training and placebo Anxiety training.
Arm Title
Anxiety + Alcohol Attention Training
Arm Type
Experimental
Arm Description
Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Arm Title
Control Training
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo Anxiety Training and placebo Alcohol training.
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Attention Training
Intervention Description
Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Attention Training
Intervention Description
Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.
Intervention Type
Behavioral
Intervention Name(s)
Control Training
Intervention Description
Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol.
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale
Description
The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).
Time Frame
Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
Title
The Daily Drinking Questionnaire
Description
The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.
Time Frame
Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current alcohol dependence
Elevated social anxiety symptoms
Willingness to consider cutting down on drinking
Exclusion Criteria:
Current psychosis
Unmanaged manic symptoms
Significant cognitive impairment
Other drug use in past month
Receiving cognitive behavioral therapy for alcohol use disorder or social anxiety
Unable to read
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua C Magee, Ph.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Department of Family and Community Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Retraining Attention to Treat Alcohol Dependence and Social Anxiety
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